FDA Orange Book
Is there a generic for Sephience?
Sephience contains sepiapterin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sephience (sepiapterin). The Orange Book shows its last listed patent expires March 6, 2042 and its last listed exclusivity ends July 28, 2032.
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Sephience products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, oral | 1GM/PACKET | Marketed (Rx) | None | 0 | None |
| powder, oral | 250MG/PACKET | Marketed (Rx) | None | 0 | None |
NDA 219666, held by PTC THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sephience patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11072614 | April 16, 2038 | Drug substance | U-4251 | 219666 |
| 12213982 | September 4, 2038 | Method of use | U-4251 | 219666 |
| 11752154 | September 4, 2038 | Drug product | U-4251 | 219666 |
| 12257252 | March 6, 2042 | Method of use | U-4250 | 219666 |
Sephience exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 28, 2030 | 219666 |
| ODE-542 | Orphan drug exclusivity | July 28, 2032 | 219666 |
Sephience NDC codes
Questions
Is there a generic for Sephience?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sephience (sepiapterin). The Orange Book shows its last listed patent expires March 6, 2042 and its last listed exclusivity ends July 28, 2032.
What is the generic name for Sephience?
The active ingredient in Sephience is sepiapterin, per the FDA Orange Book.
When does the Sephience patent expire?
The last patent listed for Sephience in the Orange Book expires March 6, 2042. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.